METOPROLOL SUCCINATE | A076640 | NESHER PHARMACEUTICALS USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lachman Consultant Services, Inc. - Citizen Petition FDA-2012-P-0698 · 3 docket documents Lachman Consultant Services, Inc., on behalf of a client, filed this petition pursuant to Section 505(b)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Metoprolol Succinate Extended-release Tablets, 12.5 mg suitable for submission as an ANDA based on the reference- | Other | 2012-07-09 | Granted | — |
Citizen Petition from KV Pharmaceutical Company FDA-2006-P-0275 · 12 docket documents KV Pharmaceutical Company filed this citizen petition under Section 505 of the Food, Drug and Cosmetic Act requesting that FDA relist U.S. Patent 5,246,714 in the Orange Book for metoprolol succinate extended release 100 mg and 200 mg tablets (Toprol-XL), refrain from approving subsequent ANDAs unti | 505(q) | 2008-12-17 | Denied | KV Pharmaceutical Company |
Sandoz Inc. - Citizen Petition FDA-2007-P-0246 · 4 docket documents Sandoz Inc. filed this citizen petition under Section 505A of the Federal Food, Drug, and Cosmetic Act requesting that the FDA delay final approval of Abbreviated New Drug Applications for generic versions of Toprol-XL (metoprolol succinate extended-release tablets, 50 mg) until the expiration of pe | 505(q) Stay Request | 2008-05-11 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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